MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-01-14 for SYSLOC MINI AVF 1 5GX1" BE 30CM W/CLAMP 864-1500-33 manufactured by Jms Singapore Pte Ltd.
[132919528]
(b)(4). Our manufacturing process was within control and no abnormality was found on the given product lot. The product lot met all the qa outgoing inspection criteria prior releasing to the market. Based on the results of reserved samples evaluation and dhr analysis, there was no abnormality found on complaint lot. Investigation was carried out for reported lot 180830331. Based on the results of dhr analysis and reserve samples evaluation, there was no abnormality found on the reported product lot. We would like to emphasize that our manufacturing process was within control and all our products met the jms qa outgoing inspection criteria prior to market release. As per the information provided by facility and (b)(4), no defect or malfunction was observed of the jms sysloc mini avf. Hence, this incident is not related to our manufacturing process. Nonetheless, briefing was conducted on 26 dec 2018 to all related operators and inspectors for their awareness on the reported defect. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[132919529]
On (b)(6) 2018, a hemodialysis patient, arrived to treatment; pre-dialysis vs obtained b/p 153/77; pulse 86; resp 17; temp 97. 8. Approximately 2 hours into the scheduled 4 hour hemodialysis treatment vs obtained were: b/p 97/52; pulse 84. The ultrafiltration was turned off and the patient's legs were elevated. The machine subsequently alarmed venous pressure and the blood pump stopped. The patient was lethargic and slow to respond verbally with the venous needle dislodged with the tape intact on the wings of the needle. Blood was noted to be flowing down the inside of the chair; a puddle of blood was under the chair. Estimated blood loss (ebl) was 1 unit. Approximately 400 mls normal saline was administered. Ems was called. Upon discharge from the facility via ems, patient was oriented with b/p 102/64; pulse 118. The patient was admitted to the hospital. 1 unit of pack red blood cells (prbcs) was infused in the er.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807350-2018-00012 |
| MDR Report Key | 8243182 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-01-14 |
| Date of Report | 2018-12-06 |
| Date of Event | 2018-11-27 |
| Date Facility Aware | 2018-12-24 |
| Report Date | 2018-12-24 |
| Date Reported to Mfgr | 2018-12-24 |
| Device Manufacturer Date | 2018-08-30 |
| Date Added to Maude | 2019-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHIA CHIN YIN |
| Manufacturer Street | 440 ANG MO KIO INDUSTRIAL PK 1 |
| Manufacturer City | SINGAPORE, 569620 |
| Manufacturer Country | SN |
| Manufacturer Postal | 569620 |
| Manufacturer G1 | PT. JMS BATAM |
| Manufacturer Street | LOT 211 JALAN BERINGIN BATMINDO IND.PARK MUKA KUNING |
| Manufacturer City | INDONESIA, |
| Manufacturer Country | ID |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSLOC MINI AVF 1 5GX1" BE 30CM W/CLAMP |
| Generic Name | JMS SYSLOC MINI A.V. FISTULA NEEDLE SET |
| Product Code | FIE |
| Date Received | 2019-01-14 |
| Model Number | 864-1500-33 |
| Lot Number | 180830331 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JMS SINGAPORE PTE LTD |
| Manufacturer Address | 440 ANG MO KIO INDUSTRIAL PK 1 SINGAPORE, 569620 SN 569620 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-01-14 |